儿童和青少年牙的随机对照试验中的选择性结果报告偏差:一项元研究研究
Livia da Rosa Oliveira1, Rokaia Ahmed Elagami1, Thais Marchezini Reis1
1School of Dentistry, Division of Pediatric Dentistry, University of São Paulo, Department of Orthodontics and Pediatric Dentistry, São Paulo, Brazil.
选择性结果报告 (SOR) 偏见在儿科牙损伤随机对照试验 (RCT) 中很普遍. 超过一半的研究显示了协议和出版物之间的差异,表明需要提高研究透明度.
科学领域:
- 牙科 牙科是指牙科的专业.
- 临床试验 临床试验
- 生物统计学 生物统计学
背景情况:
- 选择性结果报告 (SOR) 是随机对照试验 (RCT) 中的一种偏见,结果在出版物中被改变或遗漏,而不是原始协议.
- 这种偏见可能导致过度强调统计学上显著的发现.
- 这项研究调查了小儿牙损伤RCT中SOR的患病率.
研究的目的:
- 确定关于儿童和青少年牙的已发表随机对照试验 (RCT) 中选择性结果报告 (SOR) 的流行率.
- 在这个研究领域确定与SOR相关的因素.
主要方法:
- 搜索了临床试验.gov和ICTRP的儿科牙损伤RCT发表到2023年2月.
- 包括至少有两个分支和发表的一篇文章的RCT.
- 从协议和出版物中提取了结果数据以进行比较.
主要成果:
- 在包括的175项研究中,58.9%发现了选择性结果报告 (SOR).
- 在41.1%的研究中观察到主要结果的时间框架的差异.
- SOR与随访期差异 (p < 0.001) 和研究设计类型 (p = 0.048) 有意义地相关.
结论:
- 在儿科牙损伤RCT中存在SOR的高患病率,需要增加注意力.
- 实施预先注册的协议和披露偏差对于研究透明度至关重要.
- 将公布的结果与协议进行比较有助于减少研究浪费,并确保可靠的研究结果.
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